ustekinumab-srlf

FDA Drug Profile — IMULDOSA

Drug Details

Generic Name
ustekinumab-srlf
Brand Names
IMULDOSA
Application Number
BLA761364
Sponsor
Accord BioPharma Inc.
NDC Codes
6
Dosage Forms
INJECTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
USTEKINUMAB-SRLF

Indications and Usage

1 INDICATIONS AND USAGE IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) • active psoriatic arthritis (PsA). ( 1.2 ) • moderately to severely active Crohn’s disease (CD). ( 1.3 ) • moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: • moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1 ) • active psoriatic arthritis (PsA). ( 1.2 ) 1.1 Plaque Psoriasis (PsO) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn’s Disease (CD) IMULDOSA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease. 1.4 Ulcerative Colitis IMULDOSA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.